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This is one reason why trials are increasingly international
The sheer need for bodies. There are, after all, lots of places in the world where hardly anybody gets herceptin, but the internationalization has its own problems as well. I wouldn't want phase I trials moving into countries where bad results could be hushed up (not after the whole TeGenero debacle, in which six men ended up in hospital. All six men have long since recovered, although one who had been a plumber lost some figures and toes and there are concerns about long-term effects). On the other hand, I want patients to receive the best care possible, which means that some phase III trials might not be able to recruit in the US (for example, when the control arm's treatment suddenly becomes substandard).
It's not just what cancer patients deliberately take that can throw off a trial. What if it's true that oleic acid actually does make her2 positive cancer more sensitive to treatment (so far only shown at the cell level)? That could really affect how generalizable results were from countries where people use alot of olive oil or other foods high in oleic acid.
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